Patients Requiring Non-invasive VentilationNCT02090868
An Oral Intake Screening Tool for Patients Receiving Non-Invasive Ventilation
An observational study of Patients Requiring Non-invasive Ventilation, run by Imperial College London at 2 sites in United Kingdom.
Trial summary
This study aims to explore how the introduction of an oral intake screening tool can benefit patients requiring noninvasive ventilation. The Quality Care Commission has identified nutritional problems in hospital and there is much literature on the importance of nutrition when critically ill. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients Requiring Non-invasive Ventilation
- What is being tested?
- Oral Intake Screening Tool
- Type of treatment
- Pill or oral medicine
- How many people
- 0 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2013to Aug 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients; Medical High Dependency Unit Patients Staff; Full time employees on the Douglas Acute Admission Unit
Who may be able to join
- over 18 years old
- require non-invasive ventilation as defined by the protocol
- full time employees
- work in the medical high dependency unit
Who cannot join
- Patients on the Liverpool Care Pathway
- Patients requiring nocturnal non-invasive ventilation only
- Patients with a tracheostomy
- Patients with a nasogastric feeding tube insitu on admission
- Patients with a PEG/RIG tube insitu on admission
- Staff
Show all 10Show fewer
- staff only working bank or agency shifts on the medical high dependency unit
- staff who have not had formal high dependency/critical care training
- staff who do not work more than 5 shifts per month in the medical high dependency unit
- staff who have not held a full time post on Douglas Acute Admissions Unit for more than six months
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
St Marys Hospital
London, W2 1NY
Imperial College Healthcare NHS Trust
London
About this study
Official title: How the Introduction of an Oral Intake Screening Tool Can Benefit Patients Receiving Non-Invasive Ventilation
This study aims to explore how the introduction of an oral intake screening tool can benefit patients requiring noninvasive ventilation. The Quality Care Commission has identified nutritional problems in hospital and there is much literature on the importance of nutrition when critically ill. Literature is short however concerning the specialized population of those requiring noninvasive ventilation and they are a high risk group of suffering from malnutrition.
This study will potentially benefit patients by improving their nutritional care through guided assessment and nurse training.
Read more
The study will use mixed methodology, a prospective cohort study and qualitative interviews. The prospective cohort study will collect data from patients prior to the tool introduction, the control group, and post the tool introduction, the exposure group. This will enable comparisons to be made between the exposure and the control groups.
Nurses will be interviewed in semi structured focus groups prior to tool introduction and post to identify themes and sub themes to give a deeper understanding of nutrition in hospital and to examine the use of the tool in practice.
Patients will be eligible if they are over 18 and requiring noninvasive ventilation and nurses will be eligible if they work on the high dependency unit. Patients will be visited daily and have four mid arm circumference measurements at day 1, day 3, day 7 and day 14. The other daily visits will involve collecting data, which is recorded as part of routine care.
Nurses will undergo 2 focus group interviews and a teaching session. The study will take place at St Mary's hospital funded by Imperial College London. The study will be split into two periods with a two week gap in between. Each period will last until 22 patient participants have been recruited.
Read the detailed description
No patients were recruited to the study due to decreased levels of patients requiring non-invasive ventilation during the study period and time constraints owing to an academic award submission date. Six nurse participants were recruited to the study and underwent two focus group interviews, one prior to tool implementation and one post.
- Being tested
- Oral Intake Screening Tool
- Keywords
- Non-Invasive Ventilation, Bi-Level Positive Airway Pressure, Continuous Positive Airway Pressure, Critical Care, Nutrition, Malnutrition, Staff attitudes, knowledge and beliefs
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Intake Screening ToolOther
A screening tool developed from a literature review and expert opinion. It will be used by nurses to assess patients receiving non-invasive ventilation ability to eat and drink orally and suggest what actions should be taken if they are unable to do so
| Study group | Role | What they receive |
|---|---|---|
| Pre Introduction | Pre tool introduction cohort 22 patient participants who will receive standard care (no patients were recruited) | |
| Nurses | 12 nurse participants who will take part in 2 focus group interviews and a teaching session (6 nurse participants were recruited) | |
| Post Introduction | Pre tool introduction cohort 22 patient participants who's ability to eat and drink orally will be assessed using the Oral Intake Screening Tool (no patient participants were recruited) Receives: Other: Oral Intake Screening Tool |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mid Arm Circumference Change
Measured: Day 1, 3, 7, 14
Secondary outcomes (7)
Fluid Intake Change
fluid intake from all sources eg intravenous, nasogastric, oral
Measured: Daily over 14 days
fluid balance change
fluid intake minus fluid output
Measured: daily for 14 days
New formation of or worsening of existing pressure sores
Measured: daily for 14 days
new diagnosis of aspiration pneumonia
Measured: daily for 14 days
number of days requiring non-invasive ventilation
Measured: 14 days
number of days requiring level 2 care
Measured: 14 days
length of hospital stay
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startApr 2013
- Primary completionAug 2013
- Study completionAug 2013
Why it stopped: No patients recruited due to decreased levels of patients requiring non-invasive ventilation during the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patients Requiring Non-invasive VentilationStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gary Frost, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02090868
- Sponsor's protocol ID
- 13IC0065
- Status last verified
- Aug 2020
- First submitted
- 2 May 2013
- Last updated
- 27 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How the Introduction of an Oral Intake Screening Tool Can Benefit Patients Receiving Non-Invasive Ventilation
- ClinicalTrials.gov ID
- NCT02090868
- Acronym / sponsor ID
- 13IC0065
- Keywords
- Non-Invasive Ventilation, Bi-Level Positive Airway Pressure, Continuous Positive Airway Pressure, Critical Care, Nutrition, Malnutrition, Staff attitudes, knowledge and beliefs
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No patients recruited due to decreased levels of patients requiring non-invasive ventilation during the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 18 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to explore how the introduction of an oral intake screening tool can benefit patients requiring noninvasive ventilation. The Quality Care Commission has identified nutritional problems in hospital and there is much literature on the importance of nutrition when critically ill. Literature is short however concerning the specialized population of those requiring noninvasive ventilation and they are a high risk group of suffering from malnutrition.
This study will potentially benefit patients by improving their nutritional care through guided assessment and nurse training.
The study will use mixed methodology, a prospective cohort study and qualitative interviews. The prospective cohort study will collect data from patients prior to the tool introduction, the control group, and post the tool introduction, the exposure group. This will enable comparisons to be made between the exposure and the control groups.
Nurses will be interviewed in semi structured focus groups prior to tool introduction and post to identify themes and sub themes to give a deeper understanding of nutrition in hospital and to examine the use of the tool in practice.
Patients will be eligible if they are over 18 and requiring noninvasive ventilation and nurses will be eligible if they work on the high dependency unit. Patients will be visited daily and have four mid arm circumference measurements at day 1, day 3, day 7 and day 14. The other daily visits will involve collecting data, which is recorded as part of routine care.
Nurses will undergo 2 focus group interviews and a teaching session. The study will take place at St Mary's hospital funded by Imperial College London. The study will be split into two periods with a two week gap in between. Each period will last until 22 patient participants have been recruited.
Detailed description
No patients were recruited to the study due to decreased levels of patients requiring non-invasive ventilation during the study period and time constraints owing to an academic award submission date. Six nurse participants were recruited to the study and underwent two focus group interviews, one prior to tool implementation and one post.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pre Introduction | – | –Pre tool introduction cohort 22 patient participants who will receive standard care (no patients were recruited) |
| Nurses | – | –12 nurse participants who will take part in 2 focus group interviews and a teaching session (6 nurse participants were recruited) |
| Post Introduction | – | Other: Oral Intake Screening ToolPre tool introduction cohort 22 patient participants who's ability to eat and drink orally will be assessed using the Oral Intake Screening Tool (no patient participants were recruited) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients; Medical High Dependency Unit Patients Staff; Full time employees on the Douglas Acute Admission Unit
Key inclusion criteria (4 listed)
- over 18 years old
- require non-invasive ventilation as defined by the protocol
- full time employees
- work in the medical high dependency unit
Key exclusion criteria (10 listed)
- Patients on the Liverpool Care Pathway
- Patients requiring nocturnal non-invasive ventilation only
- Patients with a tracheostomy
- Patients with a nasogastric feeding tube insitu on admission
- Patients with a PEG/RIG tube insitu on admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral Intake Screening ToolA screening tool developed from a literature review and expert opinion. It will be used by nurses to assess patients receiving non-invasive ventilation ability to eat and drink orally and suggest what actions should be taken if they are unable to do so | Other | Post Introduction |
Primary outcome
Mid Arm Circumference Change
Time frame: Day 1, 3, 7, 14
7 secondary outcomes
Fluid Intake Change
Time frame: Daily over 14 days
fluid balance change
Time frame: daily for 14 days
New formation of or worsening of existing pressure sores
Time frame: daily for 14 days
new diagnosis of aspiration pneumonia
Time frame: daily for 14 days
number of days requiring non-invasive ventilation
Time frame: 14 days
number of days requiring level 2 care
Time frame: 14 days
length of hospital stay
Time frame: 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gary Frost principal investigator
Imperial College London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patients Requiring Non-invasive Ventilation, run by Imperial College London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mid Arm Circumference Change (time frame: Day 1, 3, 7, 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020.